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Snow White Ampoule

Medically reviewed on March 20, 2017

Dosage form: cream
Ingredients: Allantoin 0.000004g in 40mL, PYRIDOXINE HYDROCHLORIDE 0.0000004g in 40mL
Labeler: MICELL KOREA CO.,LTD
NDC Code: 71327-007

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

ACTIVE INGREDIENT

Allantoin (0.01%) - Skin Protectact
Pyridoxine HCl (0.001%) - Skin Protectact

INACTIVE INGREDIENT

Water, Butylene Glycol, Sodium Ascorbyl Phosphate, Sodium Hyaluronate, Niacinamide, Polyglutamic acid, Methionine, Serine, Histidine, 1,2-Hexandiol, Hydroxyethylethylcelluose, Propylene Glycol, Calcium Pantothenate, Sodium Ascorbyl Phosphate, Tocopheryl Acetate, Maltodextrin / Sodium Starch Octenylsuccinate, Camellia Sinensis Leaf Extract, Citrus Aurantium Bergamia (Bergamot) Leaf Extract, Lavendula Angustifolia (Lavender) Flower Extract, Rosa Centifolia Flower Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Alcohol, Centella Asiatica Extract, Polygonum Cuspidatum Root Extract, Scutellaria Baicalensis Root Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Chamomilla Recutita (matricaria) Flower Extract, Portulaca Oleracea Extract, Belamcanda Chinensis Root Extract, Betaine, Octanediol, Citrus grandis (grapefruit) seed extract, Artemisia princeps extract, Carbomer, Triethanolamine, PEG-60 Hydrogenated Castor Oil, Xanthan Gum, Dipotassium Glycyrrhizate, Ethylhexylglycerin, Citric Acid, Disodium EDTA

PURPOSE

Skin Protectact

WARNINGS

For skin use only.
Do not use
 on puncture wounds  on animal bites  on serious burns  on area with scratches, eczema, or dermatitis
When using this product
 avoid contact with eyes
Stop use and ask a doctor if
 you have allergy or skin disease
 rash or irritation develops and lasts
 red spots, swelling, itching, irritation and other abnormalities develops

KEEP OUT OF REACH OF CHILDREN SECTION

 if swallowed, get medical help or contact a Poison Control Center right away

INDICATIONS & USAGE SECTION

 Clean skin thorounghly before using
 After cleansing, apply toner and press lightly. Then, apply a moisturizing cream
 Use it every days in the evening according to skin condition

DOSAGE & ADMINISTRATION SECTION

 Clean skin thorounghly before using
 After cleansing, apply toner and press lightly. Then, apply a moisturizing cream
 Use it every days in the evening according to skin condition

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SNOW WHITE AMPOULE 
allantoin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71327-007
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Allantoin (ALLANTOIN) Allantoin0.000004 g  in 40 mL
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE0.0000004 g  in 40 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Methionine 
Serine 
Histidine 
Butylene Glycol 
Propylene Glycol 
Maltodextrin 
Packaging
#Item CodePackage Description
1NDC:71327-007-0140 mL in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/20/2017
Labeler - MICELL KOREA CO.,LTD (689851542)
Registrant - MICELL KOREA CO.,LTD (689851542)
Establishment
NameAddressID/FEIOperations
MICELL KOREA CO.,LTD689851542manufacture(71327-007)

 
MICELL KOREA CO.,LTD

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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